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1
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose), within 2 weeks of randomization
2
Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
3
Patients must not have evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted; the clinical indication for therapeutic anticoagulation must be clearly documented prior to enrollment and must be discussed with the principal investigator (PI); patients on greater than or equal to 2 anti-thrombotic agents, including but not limited to anti-platelet agents (nonsteroidal anti-inflammatory drugs [NSAIDS]/aspirin, clopidogrel), heparin, low molecular weight heparin, warfarin and a direct thrombin inhibitor will be excluded
4
No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors
5
Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted\r\n* NOTE: Warfarin may not be started while enrolled in the EAY131 study\r\n* Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
6
No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted)
7
No concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel); allowed anticoagulants are the following:\r\n* Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted\r\n* Low molecular weight heparins (LMWH) or unfractionated heparin is permitted\r\n* Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
8
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (or on stable dose of therapeutic anticoagulation, such as low-molecular-weight heparin, warfarin or rivaroxaban)
9
Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible
10
Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients must also be willing to receive pneumocystis jirovecii prophylaxis with sulfamethoxazole/trimethoprim, dapsone, atovaquone or inhaled pentamidine, in the event that they are randomized to TGR-1202; patients unable or unwilling to take any listed prophylaxis are NOT eligible
11
Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
12
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
13
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
14
Current necessity for full-dose anticoagulation with warfarin or its equivalent (i.e. unfractionated and/or low molecular weight heparin)
15
Patients receiving full dose anticoagulation therapy (e.g., warfarin or low molecular weight [LMW] heparin) and does not meet both of the following criteria: \r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
16
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed as long as patient has adequate coagulation defined as: activated partial thromboplastin time (aPTT) international normalized ratio (INR) =< 1.5 x upper limit of normal
17
Participants may not be currently receiving anticoagulation with coumadin for treatment or prophylaxis; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
18
Treatment with anticoagulation with warfarin, low-molecular-weight heparin, or similar agents for therapeutic purposes;
19
Currently receiving warfarin or other warfarin-derived anticoagulant for treatment, prophylaxis or otherwise; Note: Therapy with heparin, direct oral anticoagulants, low molecular weight heparin (LMWH) or fondaparinux is allowed
20
Treatment with systemic anticoagulation (e.g. warfarin, heparin, low molecular weight heparin, anti-Xa inhibitors, etc.) except aspirin
21
Required concurrent use of anti-coagulants or anti-platelet medication, with the exception of aspirin doses ?81 mg/day, low-dose SC heparin or SC low-molecular-weight heparin for DVT prophylaxis, or heparin flushes to maintain IV catheter patency
22
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
23
Adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal; patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin
24
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
25
Patient is currently receiving warfarin or other Coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
26
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, direct thrombin inhibitors, low molecular weight heparin (LMWH) or fondaparinux is allowed
27
For patients with platelets > 100,000 cells/ul (100x10^9/L) able to take aspirin daily as prophylactic anticoagulation therapy for ARMS 2+3 (patients intolerant to aspirin may use warfarin, low-molecular-weight heparin or equivalent anti-platelet therapy)
28
Anticoagulation and anti-platelet therapies are not permitted (this includes Coumadin, low molecular weight heparins, factor Xa inhibitors, aspirin and non-steroidal anti-inflammatory drug [NSAIDS] or other medicines with similar effects)
29
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
30
Therapeutic anticoagulation is allowed; the participant must be on a stable dose of anticoagulant medication (warfarin, or low molecular weight heparin [LMWH]) prior to study entry
31
Patients may NOT be on full dose anti-coagulation therapy; maintenance doses of low molecular weight heparin is permissible
32
Prothrombin time (PT) such that the international normalized ratio (INR) is < 1.5 x ULN and activated partial thromboplastin time (aPTT) < 1.5 x ULN; prophylactic heparin or low molecular weight heparin (enoxaparin or alternative anticoagulants [other than warfarin]) are acceptable
33
Patients with contraindications to any of the required concomitant drugs or supportive treatments, including hypersensitivity to anticoagulation and antiplatelet options, antiviral drugs; for example, patients with a prior history of thrombotic disease who also have a contraindication to full anticoagulation including warfarin or low molecular weight heparin, would be excluded
34
Pts must agree to take enteric-coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE)at the investigator's discretion
35
Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (e.g. lansoprazole), enteric-coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
36
Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).
37
Patients who are not already on anticoagulation should be able to take low-dose aspirin (81 mg) daily; NOTE: if aspirin is contraindicated for other reasons, the patient may be considered for the study after consultation with the study chair regarding other alternatives including possible use of warfarin or low molecular weight heparin; patients unable to take any form of prophylaxis are not eligible
38
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 12 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen
39
Patients who are on therapeutic anticoagulation with warfarin; patients on therapeutic doses of with low molecular weight heparins are eligible
40
International normalized ratio (INR) and partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
41
Participants should not take drugs that directly and durably inhibit coagulation with the exception of warfarin (coumadin) and heparin including low-molecular-weight heparin (LMWH), including enoxaparin, tinzaparin, etc
42
Adequate coagulation function as defined by International Normalized Ratio (INR) =< 1.5 and partial thromboplastin time (PTT) =< 5 seconds above the ULN (unless receiving anticoagulation therapy); patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy
43
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
44
Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
45
Patients who require concurrent treatment with antithrombotic and/or anti-platelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, and/or ibuprofen)
46
Anticoagulation with low-molecular-weight heparin (LMWH) will be permitted; patients receiving treatment with warfarin or any of the new oral anticoagulants (NOACs) (rivaroxaban, apixaban, dabigatran, or edoxaban) will be given the option to switch to LMWH
47
for subjects receiving anticoagulant, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for subjects on warfarin should be in the therapeutic range. Low molecular weight heparin (LMWH) is allowed.
48
Patients must not be on therapeutic anticoagulation (Warfarin [coumadin] and/or low molecular weight heparin are prohibited). Prophylactic anticoagulation (i.e. intraluminal heparin) of venous or arterial access devices is allowed.
49
Patients who are currently receiving therapeutic anti-coagulation with heparin, low-molecular weight heparin or Coumadin are not eligible for this trial
50
The participant requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
51
The patient requires therapeutic doses of any anticoagulant, including low molecular weight heparin (LMWH). Concomitant use of warfarin, even at prophylactic doses, is prohibited.
52
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), fondaparinux, or other oral anticoagulants is allowed
53
Able to take a minimum dose of aspirin 81 mg daily as prophylactic anticoagulation if not on warfarin, low molecular weight heparin or oral factor Xa inhibitor; patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin at doses designed to treat deep venous thrombosis
54
Heparin, warfarin or similar anti-coagulants (except. low molecular weight heparin for treatment/prophylaxis) currently or w/in 4 wks of study drug
55
International normalized ratio (INR) =< 1.5; (anticoagulation with low molecular weight heparin is allowed if on a stable dose for > 2 weeks at time of enrollment)
56
Requirement of therapeutic anticoagulant therapy with oral vitamin K antagonists; low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed; therapeutic use of low molecular weight heparin (or similar parenteral drug) for venous-thromboembolic disease is allowed
57
Use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices, as appropriate.
58
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
59
If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
60
Patients on therapeutic doses of Coumadin (> 1 mg daily); the use of therapeutic or prophylactic low molecular weight heparin or fragmin is permitted
61
Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
62
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.
63
Current and continuing anticoagulation with warfarin sodium (coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)
64
Requirement of anticoagulant therapy with oral vitamin K antagonists such as Coumadin (warfarin). Low-dose anticoagulants for the maintenance of patency in a central venous access device or the prevention of deep vein thrombosis or pulmonary embolism is allowed. Therapeutic use of low molecular weight heparin is allowed provided patients are safely able to interrupt it prior to biopsy procedures.
65
Warfarin (any dose) or full-dose anticoagulation with other agents (low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin) within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
66
Patient is using warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists or any form of anticoagulation including low molecular weight heparin
67
Subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin-related agents, thrombin or FXa inhibitors, or antiplatelet agents (eg, clopidogrel). Low-dose aspirin (?81 mg/day), low-dose warfarin (?1 mg/day), and prophylactic low molecular weight heparin are permitted.
68
Warfarin use, even if low dose warfarin is not acceptable; however, other anti-coagulants (e.g. aspirin, enoxaparin and heparin derivatives, thrombin inhibitors, etc) are acceptable
69
The patient is currently on warfarin or heparin therapy
70
Subjects who require therapeutic anticoagulation or anti-platelet therapy\r\n* Low dose aspirin (=< 100 mg/day) is allowed\r\n* Prophylactic doses of low molecular weight heparin (LMWH) are allowed if approved by study chair or designee
71
Thrombotic disorders or use of anticoagulants, such as warfarin, requiring therapeutic international normalized ratio (INR) monitoring; (treatment with low molecular weight heparin (LMWH) or direct acting oral anti-coagulants is allowed)
72
Requires therapeutic anticoagulation with warfarin at baseline\r\n* Patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug, however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed
73
STUDY TREATMENT: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 × ULN within 14 days prior to the first study treatment.\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.
74
International normalized ratio (INR) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
75
Activated partial thromboplastin time (aPPT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
76
Patients receiving anticoagulation or anti-platelet therapy are excluded; excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other nonsteroidal anti-inflammatory drug (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function; administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
77
If prior history of deep vein thrombosis (DVT)/pulmonary embolism (PE), the patient needs to be on stable doses of anticoagulation with low molecular weight heparin or oral anticoagulant for at least two weeks
78
Therapeutic anticoagulation with drugs requiring international normalized ratio (INR) monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
79
Concomitant Medications\r\n* Other planned concurrent investigational agents or other tumor directed therapies (chemotherapy, radiation) are not allowed while on this study\r\n* Concurrent use of somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months\r\n* Full dose oral anticoagulation/antiplatelet therapy is not permitted; low dose aspirin =< 81 mg/day is allowed; anticoagulation with therapeutic doses of low molecular weight heparin (LMWH) is allowed in patients who are on a stable dose of LMWH for at least 6 weeks prior to registration; treatment with warfarin is not allowed; anticoagulation in patients with brain metastases is not permitted\r\n* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed; patients must discontinue the drug at least 14 days prior to registration on the study\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug at least 14 days prior to the start of study treatment
80
International normalized ratio (INR) =< 1.5; anticoagulation is allowed only with low molecular weight heparin (LMWH); patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1 U/mL are allowed on the trial
81
Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors), platelet inhibitors (e.g., clopidogrel) or therapeutic doses of low molecular weight heparins (LMWH). Low dose aspirin for cardioprotection (per local applicable guidelines) and low-dose LMWH are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
82
Current anticoagulation therapy with therapeutic doses of warfarin (low-dose warfarin =< 1 mg/day or low molecular-weight heparin are permitted
83
Patients on coumadin must be willing to switch to an alternative subcutaneous low-molecular-weight heparin (LMWH) or oral agent (at principal investigator [PI] discretion exceptions can be permitted, as determined on a case by case basis and documented)
84
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN.\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.
85
Thromboembolic events requiring therapeutic anticoagulation; concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and factor Xa inhibitors), platelet inhibitors (e.g., clopidogrel) are prohibited\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low-dose low-molecular-weight heparin (LMWH) are permitted (in subjects who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor)\r\n* Note: Subjects with a venous filter (e.g. vena cava filter) are not eligible for this study
86
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels.
87
If patients require anticoagulation while on protocol, they should be switched from warfarin to another alternative anticoagulant such as low molecular weight heparin or oral direct factor Xa inhibitors as deemed appropriate by the treating physician for the duration they are on capecitabine (must be switched at least 1 week prior to starting capecitabine) to avoid drug-drug interaction of warfarin with capecitabine
88
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel);\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 12 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen
89
Subjects must not be on full dose oral anticoagulation such as warfarin. Low dose warfarin and prophylactic as well as therapeutic low molecular weight heparin are allowable.
90
International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN prior to study entry. Therapeutic anticoagulation with warfarin is allowed if target INR =< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for > 2 weeks (14 days) at the time of enrollment.
91
Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
92
OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy.
93
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (e.g., warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel)\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose low molecular weight heparin (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
94
Patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
95
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)\r\n* Note: low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted if started > 6 months prior to randomization; LMWH used as therapeutic anticoagulation may increase observed PTT levels in subjects; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 24 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen
96
Deep venous thrombosis within 6 months prior to study treatment, unless the patient is anti-coagulated without the use of warfarin for ?2 weeks prior to study treatment; in this situation, low molecular weight heparin is preferred
97
History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (coumadin); patients who are treated with low molecular weight heparin or fondaparinux are eligible
98
Recent occurrence (within 3 to 6 months) of a major thromboembolic event, such as pulmonary embolism or proximal deep vein thrombosis, unless stable on (>1 month) therapeutic anticoagulation (aspirin <325 milligrams (mg) daily or low-molecular-weight heparin [LMWH]). Participants with a history of clinically non-significant thromboembolic events, not requiring anticoagulation, are allowed on study.
99
Subject is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
100
Patients may not receive Coumadin while on study; patients may receive low molecular weight heparin or novel oral anticoagulants (eg. dabigatran, apixaban, rivaroxaban) provided that the dose is held 1-2 days before injections are given and biopsies are performed per the protocol; anti-platelet agents and herbal substances are allowed at the discretion of the treating endoscopist
101
Requirement for anti-coagulation with Coumadin, low molecular weight heparin and anti-thrombin inhibitors will be accepted if anticoagulation has been stable for at least 4 weeks and no recent history of prior bleeding complications
102
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
103
Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: heparin for line patency without detectable lab abnormalities for coagulation will be allowed
104
Receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
105
Within 14 days prior to the first study treatment (cycle 1, day 1): International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
106
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
107
Receiving any of the following medications:\r\n* Therapeutic doses of any anticoagulant, including low-molecular weight heparin (LMWH); concomitant use of warfarin, even at prophylactic doses, is prohibited\r\n* Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids\r\n* Colony-stimulating factors (CSFs) that cannot be held during the monitoring period for dose-limiting toxicities (DLT)
108
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
109
Patients requiring concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, antiplatelet agents (e.g. clopidogrel) or new oral anticoagulants; low-dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
110
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin) (obtained within 28 days prior to first study treatment)
111
Activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin) (obtained within 28 days prior to first study treatment)
112
Patients may not have evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted; the clinical indication for therapeutic anticoagulation must be clearly documented prior to enrollment and must be discussed with the P.I.; patients who are on greater than or equal to 2 anti-thrombotic agents, including but not limited to anti-platelet agents (non-steroidal anti-inflammatory drugs [NSAIDs]/aspirin, clopidogrel), heparin, low molecular weight heparin (LMWH), warfarin, and a direct thrombin inhibitor, will be excluded
113
International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN within 14 days prior to study entry; therapeutic anticoagulation with warfarin is allowed if target INR =< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for > 2 weeks (14 days) at the time of enrollment
114
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ? 1.5 X ULN; this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
115
International normalized ratio (INR) =< 1.5\r\n* Use of rivaroxaban, apixaban, edoxaban or warfarin is an exclusion criteria; therapy with heparin, low molecular weight heparin (LMWH), dabigatran or fondaparinux is allowed
116
Currently receiving rivaroxaban, apixaban, endoxaban, warfarin or other warfarin derived anticoagulant; therapy with heparin, low molecular weight heparin (LMWH), dabigatran or fondaparinux is allowed; if transitioning from a prohibited anticoagulant, a minimum washout of 7 days from last dose of the prohibited medication is required prior to ribociclib start
117
Requirement of anticoagulant therapy with oral vitamin K antagonists such as Coumadin (warfarin); low-dose anticoagulants for the maintenance of patency in a central venous access device or the prevention of deep vein thrombosis or pulmonary embolism is allowed; therapeutic use of low molecular weight heparin is allowed
118
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin [ASA] may use low molecular weight heparin or equivalent)
119
Require therapeutic use of anticoagulants other than daily aspirin or low molecular weight heparin
120
Deep vein thrombosis (DVT) or pulmonary embolus which require use of oral anticoagulants or, if on low molecular weight heparin, have not been on a stable dose for at least 2 weeks
121
Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring; (treatment with low molecular weight heparin [LMWH] is allowed)
122
Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or requirement for systemic anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions (eg, enoxaparin, dalteparin, fondaparinux) or oral anticoagulants (eg, apixaban, rivaroxaban, dabigatran etexilate, warfarin). Note: Use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted.
123
Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with LMW(low molecular weight Heparin) in therapeutic doses prior to randomization;
124
Able to take aspirin 81 mg orally daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin
125
Therapeutic anticoagulation with drugs requiring INR monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325mg per day)
126
Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low molecular weight heparin and heparin line flush allowed).
127
Participants must agree to ongoing anticoagulation as prophylaxis against deep vein thrombosis (DVT) using aspirin (81 or 325 mg) daily, warfarin or low molecular weight heparin, or a patient already taking another oral anticoagulant (e.g. direct thrombin inhibitors for atrial fibrillation) may continue that agent
128
International normalized ratio (INR) > 2 and/or partial thromboplastin time (PTT) > 80\r\n* Patients who are on anticoagulation medication that may not be safely held for the procedure (>= 5 days for antiplatelet agents and warfarin; >= 24 hours for low-molecular weight heparin formulations) will be excluded
129
Concomitant Medications\r\n* Corticosteroids: Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible\r\n* Investigational drugs: Patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: Patients who are currently receiving other anti-cancer agents are not eligible\r\n* CYP3A4 active agents: Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors (erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John’s wort)\r\n* Patients who are receiving systemic therapeutic treatment anticoagulation are not eligible; patients receiving prophylactic systemic anticoagulation will be allowed with heparin or low-molecular-weight heparin (LMWH) as long as eligibility PT/INR requirements are met; concomitant anticoagulation with oral anticoagulations (e.g. warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (eg. clopidogrel) are not allowed\r\n* Enzyme-inducing anticonvulsants: Patients must not have received enzyme–inducing anticonvulsants within 14 days prior to enrollment \r\n* QTc Agents: Patients who are receiving drugs that prolong QTc are not eligible
130
Anticoagulation therapy (within 7 days of Study Day 1), except low molecular weight heparins or low dose aspirin.
131
The patient is receiving therapeutic anticoagulation with warfarin, low molecular weight heparin, or similar agents; patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR =< 1.5 or PT =< 1.5 x ULN and PTT/aPTT =< 1.5 x ULN)
132
Current use of therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulants; heparin and/or low molecular weight heparins or other anticoagulants are allowed
133
Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin, heparin, apixaban, dabigatran, rivaroxaban, warfarin)
134
Warfarin is not permitted; prophylactic or therapeutic use of low molecular-weight heparin (e.g., enoxaparin) or direct thrombin inhibitors are permitted
135
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
136
Able to take aspirin 81 mg daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose (such as enoxaparin 0.5 mg/kg once daily)
137
Current use of therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulants; heparin and/or low molecular weight heparins are allowed
138
Unable to tolerate thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or dose adjusted low-molecular weight heparin
139
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
140
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
141
Therapeutic anticoagulation, including but not limited to: low-molecular weight heparin (LMWH), heparin, or warfarin; anticoagulants must be discontinued 10 days prior to the first administration of bevacizumab; prophylactic use of anticoagulants is allowed
142
Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin; if receiving warfarin, the patient must have an INR =< 3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
143
Abnormality in coagulation parameters. Received oral or parenteral anticoagulants or thrombolytic agents within 10 days of the first dose of trial drug. Low dose high molecular weight heparin is permitted if international normalized ratio is within the normal range
144
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
145
Within 3 months of registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin)
146
Within 3 months of registration: Activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin)
147
Willing and able to take aspirin (81 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
148
Has had a symptomatic venous thrombosis within 2 weeks prior to study enrollment - NOTE: Subjects with a history of a deep vein thrombosis >2 weeks prior to study enrollment who are on anticoagulation therapy with low molecular weight heparin are eligible for this study
149
Patients must not be on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
150
Subject is receiving therapeutic anticoagulation therapy; low dose anti-coagulation (e.g., low dose heparin or warfarin) for catheter prophylaxis will be permitted; use of aspirin for treatment of atrial fibrillation will also be permitted
151
Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
152
Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine; low dose (1 mg) Coumadin is allowed; intravenous and low-molecular weight heparin are permitted
153
Anticoagulants/anti-platelets: patients on therapeutic (treatment) dose of anticoagulants (e.g. warfarin, low molecular-weight heparin) are not eligible; patients are not allowed to take aspirin, clopidogrel, ticlopidine, Aggrenox; patients on prophylactic anticoagulation may be enrolled and treated on study as long as their platelet count is monitored closely and maintained at > 75,000 while they are receiving dasatinib
154
Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation (patients intolerant to acetylsalicylic acid, ASA, may use warfarin or low molecular weight heparin or other anticoagulants deemed appropriate by the principal investigator [PI])
155
Prothrombin (PT) and activated partial thromboplastin time (aPTT) =< 1.2 x upper limit of normal (ULN) prior to biopsy; patients with prior history of thrombosis/embolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team’s recommendations; low molecular weight heparin (LMWH) is preferred; if a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy
156
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
157
Receiving therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg once daily [QD])
158
International normalized ratio (INR) > 2.5 and/or partial thromboplastin time (PTT) > 80 \r\n* Patients who are on anticoagulation medication that may not be safely held for the procedure (>= 5 days for antiplatelet agents and warfarin; >= 24 hours for low-molecular weight heparin formulations) will be excluded
159
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels
160
International normalized ratio (INR) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at the first dose of study agent)
161
International normalized ratio (INR): =< 1.5 (patients on warfarin need to be converted to low-molecular-weight heparin [LMWH] during study participation to be eligible)
162
Patients who are receiving any anti-coagulation or anti-platelet therapy including, but not limited to, Clopidogrel, vitamin K antagonists (e.g. warfarin) , heparin, low molecular weight heparin, dabigatran, rivaroxaban, and apixaban
163
The subject is receiving concomitant treatment with warfarin, warfarin-related agents, or low molecular weight heparin (LMWH) at the time of study entry at therapeutic doses; low-dose warfarin (=< 1 mg/day) or LMWH at prophylactic doses are permitted
164
Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but must be willing to initiate prophylaxis with low molecular weight heparin
165
Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters). Of note, therapy with low-molecular weight heparin is acceptable as long as the INR < 2.0.
166
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g. clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
167
Partial thromboplastin time (PTT) =< institution's upper limit of normal, unless receiving therapeutic low molecular weight heparin
168
For patients with bulky disease (tumors > 5 cm); must be able to take aspirin (81 mg or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
169
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program; able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
170
Patients requiring use of warfarin for therapeutic purposes; subcutaneous heparin or fractionated heparin products are permitted if the goal is not to achieve full-dose systemic anticoagulation
171
Patients being treated with full dose warfarin are excluded. Patients with history of deep vein thrombosis or pulmonary embolus who are being treated with therapeutic doses of low molecular weight heparin or prophylactic dose anticoagulants may be enrolled.
172
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (maximum [max] =< 3) on a stable dose of oral anticoagulant for greater than 1 month or on a stable dose of low molecular weight heparin
173
Currently receiving anticoagulation with therapeutic doses of warfarin (low-molecular weight heparin is permitted)
174
Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin; use of aspirin is not an exclusion criteria
175
Prothrombin time/international normalized ratio (PT/INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to registration; patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range INR (between 2.5 and 3.5) on a stable dose of warfarin-based oral anticoagulant; or on a stable dose of low molecular weight heparin; or INR between 1.5 and 2 if a Greenfield filter is in place
176
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to aspirin may use warfarin or low molecular weight heparin) if clinically indicated
177
Patients must agree to take enteric coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (international normalized ratio [INR] 2-3) or be treated with full dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE)
178
Contraindication to any of the required concomitant drugs, including proton pump inhibitor (e.g. lansoprazole), enteric coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
179
Patients requiring warfarin therapy are excluded, low molecular weight heparin is permitted
180
Able to take aspirin 81 mg daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose (such as enoxaparin 0.5 mg/kg once daily)
181
Able to take aspirin (81 and 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin [ASA] may use warfarin or low molecular weight heparin)
182
Partial thromboplastin time =< institutional upper limit of normal, unless receiving therapeutic low molecular weight heparin
183
Current use of warfarin sodium or any other coumadin-derivative anticoagulant; participant must be off coumadin-derivative anticoagulants for at least 7 days prior to planned start of study treatment; low molecular weight heparin and factor Xa inhibitors are allowed
184
Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
185
The subject has adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x ULN\r\n* Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy
186
International normalized ratio (INR) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of randomization)
187
International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) =< 1.5 x ULN for patients who are not being treated with therapeutic anticoagulation; therapeutic or prophylactic anticoagulation is allowed if a patient has been on a stable dose of low molecular weight (LMW) heparin for > 2 weeks at the time of randomization; subjects on therapeutic or prophylactic anticoagulation including warfarin will have PTT and INR as determined by the Investigator; prophylactic use of an anticoagulant to maintain patency of a vascular access device is also allowed)
188
No warfarin therapy; low molecular weight heparin anticoagulation is permitted provided that patients have been clinically stable on anti-coagulation for at least 2 weeks prior to day 1 of study drug and meet platelet inclusion criteria; no history of active gastrointestinal (GI) bleeding or other major bleeding within previous 6 months prior to day 1 of study drug
189
Requires anticoagulation that cannot be discontinued prior to biopsy\r\n* Note: Exception if able to hold antiplatelet agents 7 days prior to the injections and biopsy\r\n* NOTE: Low molecular weight heparin (LMWH) will be allowed for bridging if on warfarin\r\n* NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed
190
administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
191
Subject is able to take prophylactic anticoagulation as detailed in section 9.1 (patients intolerant to aspirin may use warfarin or low molecular weight heparin).
192
Treatment with unfractionated heparin; patients taking an anticoagulant must use warfarin or a low molecular weight heparin
193
Patient receiving active treatment of anticoagulants (i.e. warfarin, low molecular weight heparins)
194
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ? 1.5 × ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
195
If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
196
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation [such as low-molecular-weight heparin or warfarin] should be on a stable dose.)
197
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
198
Patient is currently receiving warfarin or other Coumarin-derived anticoagulant for treatment, prophylaxis, or other reasons. Therapy with heparin, low molecular weight heparin, or fondaparinux is allowed.
199
Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325 mg/day); prophylactic and therapeutic use of anticoagulants is allowed, e.g., warfarin (1 mg once daily [QD]) for catheter prophylaxis and prophylactic low molecular weight heparin (i.e., enoxaparin [40 mg QD])
200
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
201
Therapeutic anticoagulation is allowed for patients on a stable dose of warfarin or low molecular weight heparin
202
Current use of anticoagulation; NOTE: use of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter is allowed
203
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
204
Therapeutic-dose anticoagulation (e.g., warfarin, low-molecular weight heparin [LMWH], or novel oral anticoagulants) must be discontinued and coagulation parameters must be normalized prior to the first dose of abiraterone/enzalutimide. Prophylactic anticoagulation, with low doses (per standard practice) of agents such as low molecular weight heparin (LMWH), direct thrombin inhibitors, or factor Xa inhibitors is permitted.
205
Patients may not be on warfarin, factor Xa inhibitors and direct thrombin inhibitors; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; APTT/PTT must meet the inclusion criteria; subjects taking warfarin must have their international normalized ratio (INR) followed closely
206
Within 14 days prior to registration: Partial thromboplastin time (PTT) =< institution’s ULN, unless receiving therapeutic low molecular weight heparin
207
Current use of warfarin sodium or any other coumadin-derivative anticoagulant; participants must be off coumadin-derivative anticoagulants for at least 7 days prior to starting study drug; low molecular weight heparin is allowed
208
Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation; patients intolerant to ASA may use low molecular weight heparin or equivalent; warfarin will be allowed provided patient is full anticoagulated, with an international normalized ratio (INR) of 2-3
209
Therapeutic anticoagulation with warfarin, antiplatelet agents (e.g., clopidogrel), thrombin, or Factor Xa inhibitors is not allowed; therapeutic anticoagulation with low molecular weight heparin (LMWH) is allowed as well as prophylactic anticoagulation using low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and LMWH
210
Current use of warfarin, factor Xa inhibitors and direct thrombin inhibitors; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
211
Patients may not be on coumarin anti-coagulants (warfarin, etc.); heparin, low-molecular weight heparin (LMWH), or other antithrombotic medications are permitted
212
Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin)
213
TUMOR BIOPSY SEQUENCING: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use
214
TREATMENT: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use
215
Patients receiving anticoagulation or anti-platelet therapy are excluded due to the risk of thrombocytopenia with navitoclax\r\n* Excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function\r\n* Administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed\r\n* Aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum 100 mg once daily [QD]) of aspirin if platelet counts are stable (>= 50,000/mm3) through 6 weeks of navitoclax administration \r\n* All decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
216
Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders; patients on anticoagulation with low molecular weight heparin are allowed
217
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or heparin)
218
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or factor Xa (FXa) inhibitors, and antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; therapeutic anticoagulation with LMWHs may be allowed in certain circumstances as outlined
219
Subjects on warfarin. Prophylactic anticoagulation with low molecular weight heparin\n             is allowed
220
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
221
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
222
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low?molecular weight heparin or warfarin) should be on a stable dose
223
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
224
Subject is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
225
Patients who are currently receiving therapeutic anti-coagulation with heparin, low-molecular weight heparin or Coumadin are not eligible for this trial
226
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
227
Concurrent use of anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH); medication must be stopped before time of registration; if patient has recently been on anti-coagulants other than LMWH, patient must have international normalized ratio (INR) =< 2
228
Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use; low-dose warfarin (=< 1 mg/day) is permitted
229
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
230
Patients requiring chronic anticoagulation with warfarin are excluded; patients treated with low molecular weight heparin or unfractionated heparin are eligible if on a stable dose without evidence of clinically significant bleeding for at least 2 weeks prior to enrollment
231
Current treatment or treatment within 7 days of screening with a vitamin K\n             antagonist, such as warfarin. Patients who require anticoagulation due to their\n             central line may receive an alternative agent, such as low molecular weight heparin\n             (LMWH).
232
Activated partial thromboplastin time (APTT) < 1.2 times upper limit of normal (ULN); (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
233
International normalized ratio (INR) < 1.2 times ULN; (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
234
Oral anticoagulants such as warfarin are cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) substrates and, as such, no interaction with everolimus is expected; anticoagulation with Coumadin is allowed if target INR is =< 2.0 and stable for > 2 weeks; anticoagulation with low-molecular-weight heparin (LMWH) is allowed
235
Patients who require heparin (other than low-molecular weight heparin)
236
Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration [type Innohep or equivalent])
237
Has had a symptomatic venous thrombosis within the 14 days prior to study enrollment - NOTE: Subjects with a history of a deep vein thrombosis 14 days prior to study enrollment who are on anticoagulation therapy with low molecular weight heparin are eligible for this study
238
International normalized ratio (INR) =< 1.6 (unless receiving anticoagulation therapy); patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin; if receiving warfarin, the patient must have an INR =< 3.0 and no active bleeding (i.e., no bleeding within 14 days prior to first dose of study therapy)
239
Is unable or unwilling to undergo thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.
240
Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration)
241
Anti-coagulation therapy. Aspirin, other anti-platelet agents, and low molecular weight heparin are permitted unless the investigator deems the patient is at a significant risk for bleeding.
242
International normalized ratio (INR) =< 1.5, and a partial thromboplastin time (PTT) =< 5 seconds above the ULN (unless receiving anticoagulation therapy); patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy
243
Subject is currently receiving warfarin or other Coumarin derived anti-coagulant for treatment; therapy with heparin, low molecular weight heparin (LMWH), factor Xa, or fondaparinux is allowed
244
Required concurrent use of anti-coagulants or anti-platelet medication, with the exception of aspirin doses ?81 mg/day, low-dose SC heparin or SC low-molecular-weight heparin for DVT prophylaxis, or heparin flushes to maintain IV catheter patency
245
Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin, and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel); Note: low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
246
Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin, and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel); note: low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
247
Ongoing treatment with therapeutic doses of warfarin or low molecular weight heparin (low dose warfarin up to 2 mg orally [PO] daily or use of subcutaneous low molecular weight heparin for thromboembolic prophylaxis is allowed)
248
Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin.
249
Anticoagulation/antiplatelet therapy within 7 days of Cycle 1 Day 1, including low molecular weight heparin, or warfarin.
250
Patient is currently receiving warfarin or other Coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; NOTE: therapy with apixaban, dabigatran, heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
251
Patients must be able to start low-molecular weight heparin, as prophylaxis
252
Patients are excluded if they have current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin); subjects should have not taken full-dose warfarin or equivalent for at least 2 weeks prior to randomization
253
Absence of history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia; patients with a history of deep vein thrombosis(DVT)/pulmonary embolism (PE) or thrombophilia may participate if they are willing to be on full anticoagulation during the treatment if randomized to rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R2CHOP) arm A; full anticoagulation is defined as warfarin, factor X inhibitors, or low molecular weight heparin at therapeutic doses
254
Patient must be able and willing to receive anticoagulation therapy with aspirin 70-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible
255
Current use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices.
256
SUB-PROTOCOL AIM A: Adequate coagulation function as defined by either of the following criteria:\r\n* International normalized ratio (INR) =< 1.5 x ULN\r\n* For subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the investigator’s opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy; the INR for these patients may exceed 1.5 x ULN if that is the goal of the anticoagulant therapy
257
Must be able to take low-dose aspirin, low molecular weight heparin, or other equivalent antithrombotic or anticoagulant daily as prophylactic anticoagulation.
258
Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
259
Patients on Warfarin/Dabigatran/Rivaroxaban anticoagulation may be enrolled for as long as they undergo weekly INR checks for the first 2 months of therapy. a. Patients who switch to low molecular weight heparin may be enrolled and weekly INR labs are not mandated for these patients.
260
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use low molecular weight heparin)
261
Anticoagulation/antiplatelet therapy within 7 days of C1D1, including acetylsalicylic acid, low molecular weight heparin, or warfarin
262
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
263
patients on anticoagulants for whom temporarily stop and start, supported by low molecular weight heparin (or other anticoagulation therapy at the discretion of the investigator and or per local standard of care) during vaccination and nephrectomy, is not an option
264
Prophylactic doses of heparin.
265
The concomitant use of warfarin or other vitamin K antagonists unless felt to be of significant clinical need; low molecular weight heparin or other anticoagulants may be used instead if anticoagulation is required
266
International normalized ratio (INR) </= 2 and a partial thromboplastin time (PTT) </= 5 seconds above the ULN (unless on oral anticoagulant therapy). Patients receiving full dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (except warfarin or coumarin-like anticoagulants, which are not permitted).
267
Use or need for full dose anticoagulation other than low molecular weight heparin and factor Xa inhibitors (e.g. Lovenox, fondaparinux) and no other bleeding risk
268
Current use or anticipated need for treatment with Coumadin® or other agents containing warfarin (except low dose Coumadin [1 mg or less daily] administered prophylactically for maintenance of in-dwelling lines or ports); heparin, low molecular weight heparin (LWMH), direct thrombin inhibitors and factor Xa inhibitors are allowed; rivaroxaban should be used with caution; antiplatelet agents are allowed
269
Patients currently taking anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin])
270
Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin and factor X inhibitors which do not require INR monitoring is permitted. Antiplatelet agents are prohibited throughout the study.
271
The subject requires treatment, in therapeutic doses, with oral anticoagulants such as warfarin prior to initiation of protocol therapy; low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and low molecular weight heparin (LMWH) are permitted; subjects will be permitted to use anticoagulation if treatment is required while they are enrolled on the protocol
272
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must have no active bleeding or pathological condition that carries a high risk of bleeding, and must be on a stable dose of oral anticoagulant for 14 days or on a stable dose of low molecular weight heparin for 14 days
273
Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis; patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low-molecular weight heparin or warfarin to maintain an international normalized ratio (INR) between 2.0-3.0, or any other accepted full anticoagulation regimen (e.g., direct thrombin inhibitors or factor Xa inhibitors) with appropriate monitoring for that agent; patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis; patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen
274
Patients must have no medical contra-indications to, and be willing to take, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis; patients randomized to Arms G or H who have full anticoagulation, a history of a thrombotic vascular event will be required to have therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 – 3.0, or any other accepted full anticoagulation regimen (e.g., direct thrombin inhibitors or factor Xa inhibitors) with appropriate monitoring for that agent; patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis; patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen
275
For patients requiring anti-coagulation therapy, only therapeutic low molecular weight heparin, direct thrombin inhibitors, or factor Xa inhibitors are permitted
276
Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, warfarin and others) are not eligible
277
Participant must have adequate coagulation function as defined by international normalized ratio (INR) ? 1.5 and a partial thromboplastin time (PTT) ? 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices)
278
INR and aPTT ? 1.5 x ULN • This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.
279
Current use of warfarin, factor Xa inhibitors and direct thrombin inhibitors\r\n* Note: Low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
280
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
281
Use of warfarin is prohibited; anticoagulation with low-molecular weight heparin (i.e. enoxaparin) or direct thrombin inhibitors is permitted
282
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
283
International normalized ratio (INR) and activated partial thromboplastin time aPTT =< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
284
Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
285
Current therapy with warfarin or other anticoagulants at therapeutic doses, e.g., low molecular weight heparin, fondaparinux, dabigatran, rivaroxaban, apixaban or edoxaban that are unable to be discontinued
286
Patient is currently receiving warfarin or other vitamin K antagonist; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
287
Therapeutic anticoagulation (e.g., warfarin, heparin) must be discontinued and coagulation parameters must be normalized prior to the first dose of GSK2820151. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices.
288
No therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day); no history of clinically significant hemorrhagic or thromboembolic event in the past 6 months
289
Patients receiving warfarin or other vitamin K antagonists; however, if therapeutic anticoagulation is necessary, low molecular weight heparin (LMWH) is the anticoagulant of choice
290
If currently not on anticoagulation medication, willing and able to take aspirin (81 or 325 mg) daily; if aspirin is contraindicated, the patient may be considered for the study if on therapeutic dose warfarin or low molecular weight heparin; patients unable to take any prophylaxis are not eligible
291
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on a stable dose
292
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels
293
Current use of warfarin (patients will be eligible if warfarin is discontinued and low-molecular weight heparin is used instead)
294
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
295
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
296
Ongoing therapy with oral or parenteral anticoagulants (e.g., heparin, warfarin); low-dose anticoagulants for maintenance of catheter patency are not exclusionary
297
Partial thromboplastin time (PTT) < 1.5 x ULN for institution unless patient is on planned therapy with heparin or heparin-like products obtained =< 14 days prior to registration
298
Contraindication or prior intolerance to thromboembolic prophylaxis with aspirin, warfarin or low-molecular weight heparin
299
The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
300
Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed
301
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
302
Patient is using warfarin or any other Coumadin-derivative anticoagulant; patients must be off Coumadin-derivative anticoagulants for at least seven days prior to starting the study drug; low molecular weight heparin is allowed
303
Partial thromboplastin time (PTT) =< 1 x institutional ULN and international normalized ratio (INR) =< 1.5 , unless participant is on full dose anticoagulation therapy obtained =<14 days prior to randomization; patients on full-dose anticoagulation are eligible if the following criteria are met:\r\n* Patient has an in-range INR (usually 2-3) on a stable dose of warfarin or other anticoagulant =< 14 days or is on a stable dose of low molecular weight heparin\r\n* Patient has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices)\r\n* Patients receiving anti-platelet agents are eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible
304
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
305
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must have no active bleeding or pathological condition that carries a high risk of bleeding and must be on a stable dose of oral anticoagulant for 14 days or on a stable dose of low molecular weight heparin for 14 days
306
International normalized ratio (INR), and prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) (patients who are being prophylactically anticoagulated with an agent such as Coumadin or low molecular weight heparin [LMWH] or therapeutically anticoagulated with LMWH will be allowed to participate provided they are stable and monitored at appropriate intervals per institutional guidelines throughout study)
307
Patients with known tumor thrombus or deep vein thrombosis are eligible if stable on low molecular weight heparin for ?4 weeks.
308
Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin is allowed.
309
Patients on therapeutic anticoagulation, with heparin (or low-molecular weight heparin), warfarin, or a direct thrombin inhibitor as the safety of concurrent administration of curcumin has not been established
310
Able to take aspirin, or warfarin, or low molecular weight heparin as prophylactic anticoagulation
311
Patients receiving therapeutic doses of warfarin are not eligible for participation; Note: Patients with a need for therapeutic anticoagulation should be given low molecular weight heparin or other non-warfarin product
312
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
313
Must be able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an international normalized ratio (INR) of 2 to 3
314
Requirement of anticoagulant therapy with oral vitamin K antagonists; low-dose anticoagulants for maintenance of patency of central venous access devices or prevention of deep venous thrombosis is allowed; therapeutic use of low molecular weight heparin is allowed
315
International normalized ratio (INR) and partial thromboplastin time (aPTT) ? 1.5 x ULN\r\n* This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
316
All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin) or alternative anti-coagulant
317
Patients requiring full therapeutic anticoagulation with warfarin are ineligible because therapy on this trial may result in frequent and recurrent thrombocytopenia; full therapeutic anticoagulation with heparin, low molecular weight heparin, or direct factor Xa inhibitor is permitted
318
Patients requiring full therapeutic anticoagulation including warfarin, heparin, low-molecular weight heparin, or direct factor Xa inhibitor are ineligible because therapy on this trial may result in frequent and recurrent thrombocytopenia; patients requiring prophylactic dose anticoagulation may be eligible after discussion with the principal investigator
319
Patients NOT on warfarin must have a prothrombin time (PT)/international normalized ratio (INR) < 1.4 within 14 days prior to registration\r\n* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet BOTH of the following criteria within 14 days prior to registration:\r\n** No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n** In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of LMW heparin
320
Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring. (Treatment with low molecular weight heparin is allowed.)
321
Patients on therapeutic anticoagulation with low molecular weight heparins, fondaparinux, rivaroxaban or warfarin are eligible, provided that they are on a stable dose of anticoagulants; patients who are currently receiving antiplatelet therapy of prasugrel or clopidogrel or antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or low doses of acetylsalicylic acid (up to 100 mg daily) are also eligible
322
Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (eg, lansoprazole), enteric-coated aspirin, allopurinol or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
323
Treatment with therapeutic doses of coumarin-type anticoagulants (maximum daily dose of 1 mg allowed for port line patency permitted); low molecular weight heparin (LMWH) will be allowed
324
Current use of therapeutic anticoagulants such as warfarin or heparin
325
Patients who participate in this study must be willing and able to tolerate prophylactic anticoagulation either with aspirin, low-molecular weight heparin (LMWH), or warfarin
326
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within 14 days prior to registration
327
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
328
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin), unless baseline prothrombin time (PT) or partial thromboplastin time (PTT) is >= 1.5 ULN, in which case thromboprophylaxis is not required
329
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
330
Anticoagulants other than low molecular weight heparin.
331
History of pulmonary embolus within 3 months or deep venous thrombosis (DVT) within 4 weeks of enrollment; patients on anticoagulation must be on a stable dose of warfarin with a therapeutic-range international normalized ratio (INR) or on a stable dose of low molecular weight heparin
332
Patients who require therapeutic doses of Coumadin derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted, provided the patient’s PT/INR is =< 1.5; Coumadin doses of up to 2 mg daily are permitted for prophylaxis of thrombosis
333
Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; note: low molecular weight heparin is permitted provided the patient’s PT INR is =< 1.5
334
Stable dose Coumadin anticoagulation is allowed, providing that anticoagulation can be safely held to an international normalized ratio (INR) within normal range for the purpose of tumor biopsy; low molecular weight heparin (LMWH) is the preferred method of anticoagulation
335
The participant requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa (FXa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
336
Patients on warfarin will be excluded from the trial if they cannot be switched to an acceptable alternative medication (i.e. low molecular weight heparin [LMWH]); prolongation of prothrombin time (PT) and International Normalized Ratio (INR) were observed in patients receiving vorinostat concomitantly with coumarin-derivative anticoagulants
337
Able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an INR of 2 or 3.
338
Patients must not have any evidence of bleeding diathesis or be on any therapeutic anticoagulation such as low molecular weight (LMW) heparin or warfarin for deep vein thrombosis (DVT) treatment
339
Must have been able to take concurrent aspirin 81 to 325 mg daily (or enoxaparin 40 mg subcutaneously daily [or its equivalent] if allergic to aspirin), per published standard or institutional standard of care, as prophylactic anticoagulation. NOTE: For participants with prior history of deep vein thrombosis (DVT), low-molecular-weight heparin (LMWH) was mandatory.
340
Patients on therapeutic dose anti-coagulation with warfarin, low molecular weight heparin (LMWH), or other anti-coagulants will be allowed to participate in the study; however, the anti-coagulants should be held pre- and post- research biopsy (when applicable) as per institutional standards; the risks of a temporary hold of anti-coagulation should be carefully considered and explained to the patient as part of the informed consent process; if it is not felt to be in the best interest of the patient to have anti-coagulation held, the patient may still enter the study, but should not undergo a research biopsy
341
International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5; anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low-molecular weight (LMW) heparin for > 2 weeks at time of randomization
342
History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; Note: Patients with recent DVT who have been treated with therapeutic anticoagulation including Coumadin or any low molecular weight heparin for at least 6 weeks are eligible
343
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)
344
Contraindication to aspirin; if unable to take aspirin, contraindication to warfarin or low molecular weight heparin
345
Current, ongoing treatment with full-dose warfarin; however patients may be on stable doses of a low molecular weight heparin are allowed (i.e. Lovenox)
346
Patients on full-dose anticoagulation are eligible if the following criteria are met:\r\n* Patient has an in-range international normalized ratio (INR) (usually 2-3) on a stable dose of warfarin or is on a stable dose of low molecular weight heparin\r\n* Patient has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices) \r\n* Patients receiving anti-platelet agents are eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible
347
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin [ASA] may use warfarin or low molecular weight heparin)
348
Patients requiring treatment doses of heparin for any reason; the use of heparin flushes for maintenance of central venous catheters is permitted
349
Patients requiring warfarin/Coumadin for therapeutic anticoagulation; low molecular weight heparin is allowed
350
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
351
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or factor Xa (FXa) inhibitors, and antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
352
Active bleeding diathesis or current treatment with therapeutic doses of sodium warfarin (Coumadin) or other vitamin K active agents (Note: mini-dose of Coumadin (e.g., 1 mg/day) or anti-coagulants given to maintain intravenous line patency, as well as unfractionated or low molecular weight heparin therapy are permitted)
353
Subjects who require heparin other than low-molecular weight heparin
354
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
355
Patients currently requiring anticoagulation with coumadin (nonsteroidal anti-inflammatory drugs [NSAIDs] and prophylactic dose heparin are allowed)
356
International normalized ratio (INR) =< 1.2 x ULN; partial thromboplastin time (PTT) =< 1.5 x ULN, within 14 days of registration; therapeutic anticoagulation with warfarin is allowed if target INR =< 3 on a stable dose of warfarin or on a stable dose of low molecular weight (LMW) heparin for > 2 weeks (14 days) at time of randomization
357
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
358
Anti-coagulation at baseline:\r\n* For the first 20 patients to register to trial, no anti-coagulation is allowed; patients requiring therapeutic anticoagulation with warfarin or therapeutic or prophylactic therapy with a low-molecular weight heparin at baseline are excluded\r\n* For all subsequent patients screened, patients requiring therapeutic anticoagulation with warfarin at baseline are excluded; however, therapeutic or prophylactic therapy with a low-molecular weight heparin at baseline is acceptable
359
International normalized ratio (INR) =< 2.0; anticoagulation is allowed if target INR =<, 2.0 on a stable dose of warfarin or if patient on a stable dose of low molecular weight (LMW) heparin for > 1 weeks at time of enrollment
360
International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of randomization)
361
Active bleeding tendency; NOTE: patients on therapeutic anticoagulation should be monitored carefully to maintain therapeutic level of anticoagulation to avoid increased risk of bleeding due to concurrent drug induced thrombocytopenia; it is suggested that patients who require anticoagulation therapy while on therapy use low molecular weight heparin (LMWH)
362
Patient must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
363
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin) if no additional risk factor for venous thromboembolism (VTE) other than myeloma diagnosis according to International Myeloma Working Group (IMW) guidelines
364
Able to take low molecular weight heparin or warfarin if >= 1 additional risk factor for VTE according to IMW guidelines
365
Patients receiving current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin) are NOT excluded
366
Able to take aspirin (81 or 325mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
367
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
368
Clinically significant bleeding within 4 weeks of screening, current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors unless these medications can be safely discontinued 14 days prior to AMG-232 administration; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
369
OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy.
370
All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (Coumadin) or alternative anti-coagulant
371
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
372
Able to take aspirin 325 mg or 81 mg daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use Coumadin or low molecular weight heparin)
373
History of adverse reaction to heparin such as heparin-induced thrombocytopenia
374
The patient has a prothrombin time (PT) (international normalized ratio [INR]) =< 1.5 and a partial thromboplastin time (PTT) =< 3 seconds above the upper limits of normal if the patient is not on anticoagulation; if a patient is on full-dose anticoagulants, the following criteria should be met for enrollment: \r\n* The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of low molecular weight (LMW) heparin\r\n* The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
375
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
376
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon), direct thrombin inhibitors, direct factor Xa inhibitors or heparin or low-molecular weight heparins at therapeutic doses
377
This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low molecular weight heparin or warfarin) should be on a stable dose.
378
Therapeutic anticoagulation (e.g. warfarin, heparin, etc.) must be stopped at least 7 days prior to the first dose of MK-8628. Low-dose low molecular weight heparin (LMWH) is permitted
379
Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
380
Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
381
Patients who are currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant; low molecular weight heparin is allowed
382
International normalized ratio > 1.5 on anticoagulant therapy, active bleeding on low molecular weight heparin, or chronic condition with a high risk of bleeding.
383
Ongoing anticoagulant therapy (eg, aspirin, coumadin, heparin).
384
Ongoing anticoagulant therapy (eg, aspirin, coumadin, heparin).
385
Participants who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin
386
Patients on warfarin will not be allowed on the study; patient on low molecular heparin or anti direct factor Xa inhibitor (Xa) drugs will be allowed
387
Use of warfarin is not allowed; patient is recommended to switch to low molecular weight heparin (LMWH) before participating in this study
388
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
389
Had full-dose anticoagulation with heparin, enoxaparin, dalteparin, other LMWH, a/or other anticoagulants w/in 90 days before first dose of M402
390
Patients receiving therapeutic anticoagulation; prophylactic anticoagulation of venous access devices is allowed; caution should be taken on treating patients with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding
391
Patients with thromboembolic disease cannot be on Coumadin, but low molecular heparins are allowed
392
SUNITINIB MALATE ARM: Patients who require use of therapeutic doses of Coumarin-derivative anticoagulants such as warfarin are excluded; note: low molecular weight heparin is permitted provided the patient’s prothrombin time (PT) international normalized ratio (INR) is < 1.5
393
Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: heparin for line patency without detectable lab abnormalities for coagulation will be allowed
394
Participants on any dose of warfarin or are on full dose anticoagulation with other agents including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within 7 days prior to study enrollment; participants on prophylactic doses of low molecular weight heparin are allowed
395
Patients must be able to take daily prophylactic anticoagulation medication, such as: aspirin (81 or 325 mg) warfarin, low molecular weight heparin, or other medications as clinically indicated
396
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, thrombin or factor Xa inhibitors; aspirin (up to 325 mg/day), low-dose warfarin (=< 1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted
397
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
398
Are receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents. Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that they are on low-molecular weight heparin or oral factor Xa inhibitors.
399
Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
400
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, thrombin or factor Xa (FXa) inhibitors, and antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; therapeutic anticoagulation with LMWHs may be allowed in certain circumstances
401
International normalized ratio (INR) and partial thromboplastin time (PTT) =< 3.0 x UNL; NOTE: anticoagulation is allowed if target INR =< 3.0 x UNL on a stable dose of warfarin or on a stable dose of low molecular weight heparin for > 2 weeks at time of registration
402
Ongoing need for therapeutic anticoagulants (full dose heparin, warfarin, factor Xa or direct thrombin inhibitors; rivaroxaban, apixaban, dabigatran) chronic use of aspirin or anti-platelet agents (ticlopidine or clopidogrel)
403
Isolated CABG or single valve repair/replacements are allowed only if either (a) AT level is less than 80% OR (b) preoperative heparin is received (unfractionated heparin [UFH] for at least 12 hours; low- molecular-weight heparin [LMWH] for more than 5 days).
404
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
405
Participants receiving therapeutic anti-coagulation or anti-platelet (anti-aggregant) therapies, except for therapeutic enoxaparin or low dose aspirin. Use of subcutaneous heparin prophylaxis, including low molecular weight heparin is also permitted
406
Patients on full-dose anticoagulants (e.g., warfarin) with prothrombin time (PT) international normalized ratio (INR) > 1.5 are eligible provided that both of the following criteria are met:\r\n* The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\r\n* The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
407
No active anticoagulation within 7 days of study Day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.
408
Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
409
Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin
410
Coagulation studies with prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) within normal limits (± 15%); if the patient is on Coumadin – we would switch the patient to low molecular weight (LMW) heparin product such as fondaparinaux (Arixtra) or enoxaprin (Lovenox); an anti-factor Xa test should be available demonstrating adequate anti-coagulation on the low molecular weight heparin (LMWH) (therapeutic range 0.4-0.8); however, if this is not possible then INR must be kept =< 3
411
Current use of anticoagulants at therapeutic doses within 7 days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin is permitted
412
Patients receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started >= month prior to enrollment on this study; patients may be on low molecular weight heparin or direct factor Xa inhibitors
413
Current use of therapeutic warfarin. NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted
414
Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed.
415
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
416
Current use of therapeutic warfarin. Low-molecular-weight heparin and prophylactic low-dose warfarin are permitted
417
Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving lowdose aspirin and/or non-steroidal anti-inflammatory agents.
418
Therapeutic anticoagulation (except for low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
419
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
420
Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin
421
History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin. Note: Occlusion of a central line is not exclusion.
422
International normalized ratio (INR) and partial thromboplastin (PTT) =< 3.0 x ULN (anticoagulation is allowed if target INR =< 3.0 x ULN on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of registration)
423
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day) and prophylactic low molecular weight heparin (LMWH) are permitted
424
Subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs (e.g., aspirin, clopidogrel, etc.) or herbal supplements that affect platelet function, with the exception of low molecular weight heparin or heparin that are used to maintain the patency of a catheter
425
Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed.
426
Patients who are on anticoagulation medication that may not be safely held for the procedure (>= 5 days for antiplatelet agents and warfarin; >= 24 hours for low-molecular weight heparin formulations) will be excluded
427
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
428
Patients may not be on anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH)
429
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted (please note that there may be cases in which patients on study require anticoagulation for deep vein thrombosis [DVT]/pulmonary embolism [PE] management; this does not necessitate taking the patient off study)
430
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 100 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
431
Warfarin and its derivatives are not allowed; patient can be receiving low molecular weight heparin if clinically indicated
432
Patients on full dose anticoagulants or any dose of warfarin; patients on prophylactic dose of low-molecular weight or unfractionated heparin are allowed.
433
Concurrent use of systemic low molecular weight heparin or low dose warfarin
434
Patients requiring therapeutic anticoagulation (e.g., warfarin, dabigatran, heparin, or low molecular weight heparins [Lovenox, dalteparin])
435
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant of aspirin or at increased risk of venous thrombosis may use warfarin or low molecular weight heparin)
436
Patients on full-dose anticoagulants (e.g., warfarin) with prothrombin time (PT) international normalized ratio (INR) > 1.5 are eligible provided that both of the following criteria are met:\r\n* The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\r\n* The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
437
International normalized ratio (INR) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of study initiation)
438
For those participants receiving warfarin (Coumadin), unfractionated heparin, or low-molecular weight heparin therapy, the applicable coagulation parameter that is being monitored must be within the accepted therapeutic ranges for those indications\r\n* Note: transfusions and/or growth factor dependent participants are not excluded if the above parameters can be achieved with such support
439
Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except for the use of low dose coumarin-type anticoagulants or low molecular weight heparin for prophylaxis against central venous catheter thrombosis
440
Able to receive prophylactic anticoagulation with aspirin, warfarin or low molecular weight heparin when required for lenalidomide administration
441
No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
442
Prothrombin time (PT) (international normalized ratio [INR]) > 1.5, unless the patient is on full dose anticoagulants; if so, the following criteria must be met for enrollment:\r\n* The subject must have an in-range INR (usually between 2-3) on a stable of low molecular weight heparin; anticoagulation with warfarin is not allowed
443
PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists]. Low-dose aspirin is permitted (</= 100 mg daily).
444
Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
445
International normalized ratio (INR) < 1.5 (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at the time of registration)
446
Able to take aspirin daily as prophylactic anticoagulation therapy (subjects intolerant to aspirin may use warfarin or low-molecular-weight heparin).
447
Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia
448
Patients receiving therapeutic anticoagulation should be switched to low molecular weight heparin (LMWH) before the first cycle of obinutuzumab
449
Pulmonary embolus or thrombosis of the deep venous system (deep vein thrombosis [DVT]) within 2 weeks of starting study treatment; patients who had a history of thromboembolic disease should be stable on therapeutic anticoagulation using low molecular weight (LMW) heparin for at least 2 weeks prior to the start of study treatment; use of warfarin (or derivatives) is not allowed at the start of study treatment
450
If currently not on anticoagulation medication, willing and able to take aspirin (325 mg) daily; note: if aspirin is contraindicated, the patient may be considered for the study after if on therapeutic dose warfarin or low molecular weight heparin; patients unable to take any prophylaxis are not eligible
451
Currently receiving antiplatelet therapy of prasugrel or clopidogrel, or full dose anticoagulation treatment with therapeutic doses of warfarin; Note: treatment with low doses of warfarin (e.g., =< 2 mg/day ) for line patency allowed; also, low molecular weight heparins, fondaparinux, antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or locally accepted low doses of acetylsalicylic acid (up to 100 mg daily) may be administered concomitantly with dovitinib with caution
452
Patient is currently receiving warfarin or other Coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
453
Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to registration; patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (between 2.5 and 3.5) on a stable dose of warfarin-based oral anticoagulant; or on a stable dose of low molecular weight heparin; or INR between 1.5 and 2 if a Greenfield filter is in place
454
Patient is in need of anticoagulation therapy except for low-dose heparin or low-dose coumadin for maintenance of patency of central venous access or prevention of deep vein thrombosis (DVT)
455
Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin), fibrinolysis and high dose anti-platelet therapy (ex. Plavix 150 mg); prophylactic low dose heparin, heparin flush for maintenance of intravenous devices, prophylactic use of anti-platelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, clopidogrel 75 mg/d, or equivalent doses) should be allowed
456
Patients on full dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
457
Low molecular weight heparin or Novel oral anti-coagulant: stable dose within 14 days prior to registration
458
Thrombologic event within 3 weeks of treatment start date, unless stable on anticoagulation with low molecular weight heparin (LMWH) or Factor Xa inhibitor for at least 2 weeks
459
Current or recent use of dipyridamole, ticlopidine, clopidogrel, cilostazol is excluded; aspirin (=< 325 mg per day) is allowed; prophylactic anticoagulation with oral or parenteral anticoagulants for the patency of venous access devices or other indications is allowed, therapeutic use of low-molecular weight heparin (such as enoxaparin), and factor Xa inhibitors are allowed; use of warfarin is prohibited
460
Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
461
Diagnosis of symptomatic venous thromboembolism requiring therapeutic-dose anticoagulation (unfractionated or low-molecular weight heparin or oral anticoagulants) throughout the period of hematopoietic recovery
462
No therapeutic heparin (including low molecular weight) or Coumadin use
463
Known bleeding disorders or taking any dose of warfarin or heparin
464
Concomitant treatment with full dose warfarin (coumadin) is NOT allowed; however, treatment with low molecular weight heparin (LMWH) (such as enoxaparin or dalteparin) or rivaroxaban is allowed; patients on full dose warfarin (coumadin) must be transitioned to either LMWH or rivaroxaban prior to administration of any study related drugs
465
Therapeutic dose anticoagulation with warfarin, low molecular-weight heparin, or similar agents.
466
Patient is using warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists; patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug; low molecular weight heparin is allowed; patients with congenital bleeding diathesis are excluded
467
Known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia
468
Known bleeding disorders or taking any dose of warfarin or heparin
469
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
470
Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose; patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate
471
If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
472
Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose; patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate
473
History of allergic reactions attributed to heparin or low molecular weight heparin
474
Received any type of pharmacologic thromboprophylaxis (e.g. low molecular weight heparin or heparin) for > 48 hours during current hospitalization
475
Chronic anti-coagulation with warfarin; patients on low molecular weight heparin or fondaparinux may be enrolled
476
Current or planned use of anticoagulant drugs such as: warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox throughout the course of the study
477
History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolisms) in the preceding year
478
Obtained within 28 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin)
479
Obtained within 28 days prior to registration: Activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin)
480
History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year
481
For patients undergoing a research only biopsy: requirement for anticoagulation with heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban, warfarin, aggrenox, fondaparux, ticagrelor, etc (aspirin and other nonsteroidal antiinflammatory drugs [NSAIDs] are ok but should be held prior to biopsy in accordance with institutional standard of care)
482
Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
483
International normalized ratio (INR) < 1.5, unless patient is on therapeutic anticoagulation where a therapeutic INR is acceptable; anticoagulation with low molecular weight heparin or warfarin, where medically indicated, is permitted*
484
Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin.
485
No use of full dose, therapeutic anti-coagulation; however, low dose warfarin for catheter prophylaxis or acetylsalicylic acid are acceptable
486
Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel, heparin, or warfarin).
487
Anticoagulation: if currently receiving therapeutic anticoagulation with heparin, low-molecular weight heparin, or Coumadin, not eligible
488
Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel, coumadin, heparin, or warfarin) that cannot be held to permit tumor biopsy).
489
No antiplatelet or anticoagulation medications allowed within 7 days prior to talimogene laherparepvec injection except low-dose heparin needed to maintain venous catheter patency.